Alprazolam immediate release (IR) tablets are currently approved for the management of anxiety disorder or \r\nthe short-term relief of symptoms of anxiety. A sublingual (SL) formulation of alprazolam, which disintegrates in \r\nthe mouth without the need for additional fluids, has been developed. The aim of this study was to determine if the \r\nalprazolam SL 1 mg tablet was bioequivalent to the alprazolam IR 1 mg tablet in healthy volunteers.\r\nIn this randomized, open label, two-way crossover, single dose study, subjects were randomized to receive a \r\nsingle alprazolam 1 mg IR tablet during one dosing period and a single 1 mg SL tablet during the other dosing period. \r\nThe primary pharmacokinetic endpoints were area under the plasma concentration-time profile from time zero to the \r\ntime of the last quantifiable concentration AUC(0-t) and maximum plasma concentration (Cmax). Adverse events (AEs) \r\nwere monitored throughout the study. Bioequivalence was concluded if the 90% confidence intervals (CI) for the ratio \r\nof adjusted geometric means for both AUC(0-t) and Cmax were wholly within 80%-125%.\r\nParticipants were mostly male (27/28 [96.4%]) and had a mean (standard deviation) age of 35.9 (8.2) years. For \r\nthe alprazolam 1 mg SL tablet relative to the alprazolam 1 mg IR tablet, the ratio of adjusted geometric means (90% \r\nCI) for AUC(0-t) and Cmax were 95.43% (91.74%, 99.27%) and 88.27% (83.68%, 93.11%), respectively. The incidence \r\nof AEs was similar during both treatment periods: 24 participants reported 39 AEs during the alprazolam 1 mg IR \r\ntreatment period, and 23 participants reported 38 AEs during the alprazolam 1 mg SL treatment period.\r\nBioequivalence was demonstrated between the alprazolam IR and SL 1 mg tablets, suggesting that the clinical \r\nperformance of the SL tablet will be similar to that of the IR tablet.
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